AccessGUDID - DEVICE: Stieber (00850023646927)

GUDID

Device Identifier (DI) Information

Brand Name: Stieber
Version or Model: Stieber Rib Grip Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SBRBKC
Company Name: Automated Medical Products Corp.

Primary DI Number: 00850023646927
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053435368 *Terms of Use

Device Description: Stieber Kit: Two Piece Horizontal Bar, Two vertical poles and two Grooved 3D Swinger Clamps

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45181	Surgical retraction system, reusable	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 19340d27-aa71-4ef1-a2e2-b07132d84fa2
Public Version Date: July 27, 2023
Public Version Number: 1
DI Record Publish Date: July 19, 2023